Leveraging the Expertise of the CTSA Program to Increase the Impact and Efficiency of Clinical Trials
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Published:2023-10-05
Issue:10
Volume:6
Page:e2336470
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ISSN:2574-3805
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Container-title:JAMA Network Open
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language:en
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Short-container-title:JAMA Netw Open
Author:
Harris Paul A.12, Dunsmore Sarah E.3, Atkinson Jane C.3, Benjamin Daniel Kelly45, Bernard Gordon R.16, Dean J. Michael7, Dwyer Jamie P.78, Ford Daniel E.9, Selker Harry P.101112, Waddy Salina P.3, Wiley Kenneth L.3, Wilkins Consuelo H.1613, Cook Sarah K.1, Burr Jeri S.7, Edwards Terri L.1, Huvane Jacqueline5, Kennedy Nan1, Lane Karen914, Majkowski Ryan14, Nelson Sarah1, Palm Marisha E.101112, Stroud Mary1, Thompson Dixie D.78, Busacca Linda15, Elkind Mitchell S. V.16, Kimberly Robert P.17, Reilly Muredach P.15, Hanley Daniel F.914, Greenberg Rachel18, Zimmerman Kanecia18, Smith Brian18, Rockhold Frank18, Poole Lori18, Hickerson Jesse18, Pham Eilene18, Marion Eve18, Boyle Helen18, Miller Vincent18, Sutton Sonya18, Jones Michelle18, Abbott-Grimes Princess18, McBee Nichole18, Mould Andrew18, Eyzaguirre Lindsay18, Singleton Megan18, Maddox-Regis Janelle18, Hillery Shannon18, Nanni Angeline18, Hildreth Meghan18, Pessoa-Gingerish Cecilia18, Bartlett Emily18, Cohen Theodora18, Wieber Cortney18, Vermillion Krista18, Rothwell Erin18, Watt Kevin18, Sward Kathy18, VanBuren John M.18, Pautler Mary18, Kay Marie18, Bridges Jordan18, Ellis Krista18, Sebahar Francis18, Unsicker Eun Hea18, Vasenina Valeriya18, Morris Talmage18, Aponte Michelle18, Johnson Ann18, Risenmay Annie18, Rigtrup Lisa18, Henderson Gary18, Pate Ammon Leon18, Lopez Monse18, Boone Leslie18, Byrne Loretta18, Helmer Tara18, Tischbein Maeve18, Dunkel Leah18, Mayers Stephanie18, Quarles Kaysi18, Bell Jasmine18, Swindell Bridget18, Ichimura Jabari18, Ray Devan18, Rantala Caitlin18, Eidenmuller Jessica18, Serdoz Emily18, Dilts Natalie18, Crenshaw David18, Henderson Brooklyn18, Vance Meghan18, Burts Delicia18, Grant Dione18, Hamilton Jahi18, Schorr Matt18, Lawrence Colleen18, Bernui Meredith18, Budine Taylor18, Baig Amna18, Christodoulou Joseph18, Cohen Jodie18, Chen Tiffany18, Dunagan Julia18, Lloyd Wendy18,
Affiliation:
1. Vanderbilt Institute for Clinical and Translational Research, Nashville, Tennessee 2. Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee 3. National Center for Advancing Translational Sciences, Bethesda, Maryland 4. Duke University School of Medicine, Durham, North Carolina 5. Duke Clinical Research Institute, Durham, North Carolina 6. Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee 7. University of Utah Health, Salt Lake City 8. Utah Clinical and Translational Sciences Institute, Salt Lake City 9. Johns Hopkins Institute for Clinical and Translational Research, Baltimore, Maryland 10. Department of Medicine, Tufts University, Boston, Massachusetts 11. Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts 12. Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts 13. Department of Internal Medicine, Meharry Medical College, Nashville, Tennessee 14. Johns Hopkins University School of Medicine, Baltimore, Maryland 15. Irving Institute for Clinical and Translational Research, Columbia University Irving Medical Center, New York, New York 16. Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, New York 17. Center for Clinical and Translational Science, University of Alabama at Birmingham 18. for the Trial Innovation Network
Abstract
ImportanceMulticenter clinical trials play a critical role in the translational processes that enable new treatments to reach all people and improve public health. However, conducting multicenter randomized clinical trials (mRCT) presents challenges. The Trial Innovation Network (TIN), established in 2016 to partner with the Clinical and Translational Science Award (CTSA) Consortium of academic medical institutions in the implementation of mRCTs, consists of 3 Trial Innovation Centers (TICs) and 1 Recruitment Innovation Center (RIC). This unique partnership has aimed to address critical roadblocks that impede the design and conduct of mRCTs, in expectation of accelerating the translation of novel interventions to clinical practice. The TIN’s challenges and achievements are described in this article, along with examples of innovative resources and processes that may serve as useful models for other clinical trial networks providing operational and recruitment support.ObservationsThe TIN has successfully integrated more than 60 CTSA institution program hubs into a functional network for mRCT implementation and optimization. A unique support system for investigators has been created that includes the development and deployment of novel tools, operational and recruitment services, consultation models, and rapid communication pathways designed to reduce delays in trial start-up, enhance recruitment, improve engagement of diverse research participants and communities, and streamline processes that improve the quality, efficiency, and conduct of mRCTs. These resources and processes span the clinical trial spectrum and enable the TICs and RIC to serve as coordinating centers, data centers, and recruitment specialists to assist trials across the National Institutes of Health and other agencies. The TIN’s impact has been demonstrated through its response to both historical operational challenges and emerging public health emergencies, including the national opioid public health crisis and the COVID-19 pandemic.Conclusions and RelevanceThe TIN has worked to reduce barriers to implementing mRCTs and to improve mRCT processes and operations by providing needed clinical trial infrastructure and resources to CTSA investigators. These resources have been instrumental in more quickly and efficiently translating research discoveries into beneficial patient treatments.
Publisher
American Medical Association (AMA)
Cited by
6 articles.
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